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Data / Medical devices / Gastroscope And Accessories, Flexible/Rigid / China

FDA-registered makers of Gastroscope And Accessories, Flexible/Rigid in China: 10 establishments

10 establishments in China are registered with the FDA to make Gastroscope And Accessories, Flexible/Rigid (product code FDS). 4 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.

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Device
Gastroscope And Accessories, Flexible/Rigid
Product code
FDS
Country
China

Makers of Gastroscope And Accessories, Flexible/Rigid in China

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Alton Shanghai Medical Instruments Co LtdShanghai, ChinaComplaint file establishment, Manufacturer1May 30, 2025000api.fda.gov
Daichuan Medical (Shenzhen) Co., LtdShenzhen Guangdong, ChinaManufacturer1September 2, 2020000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.Nanjing Jiangsu, ChinaManufacturer1June 27, 2025000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.NAN JING Jiangsu, ChinaManufacturer1June 27, 2025000api.fda.gov
Guangzhou Red Pine Medical Instrument Co.,ltd.Guangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Hangzhou AGS MedTech Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Sonoscape Medical Corp.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Sonoscape Medical Corp.SHENZHEN Guangdong, ChinaManufacturer0000api.fda.gov
Sumitomo Bakelite (Dongguan) Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Yangzhou Fartley Medical Instrument Technology Co., LtdYangzhou Jiangsu, ChinaManufacturer0000api.fda.gov

Updated November 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.